2023 - Antibody Reduction in Bioprocessing: Analytical Detection and Steps for Mitigation

Antibody reduction is the spontaneous degradation of inter-chain disulfide bonds resulting in a build-up of partial related substances of an IgG in bioprocess streams. This can lead to decreased product yield and altered batch quality and efficacy profile. Process factors known to favor antibody reduction are the antibody subclass, high shear force during harvest, low dissolved oxygen during harvest and storage conditions (pH, temperature, time) of harvest material. This webinar will highlight a case study of a new monoclonal antibody undergoing process optimization where antibody reduction was encountered showing partial related substances present at 38 percent by area.
The webinar will focus on the analytical detection and characterization technologies employed and the in-process control data used to understand the potential sources of degradation in antibody reduction. A capillary electrophoresis system was used to first detect the related substances present in the demonstration run drug substance using non-reduced CE-SDS analysis. The results were verified by retesting and by altering sample preparation conditions to eliminate method artifacts as a potential source of the species. Full analytical panel testing was performed on in-process retains to identify key process factors for the reduction and to better understand the nature and impact of the related substances in the product batch. Additional testing included SDS-PAGE, SE-HPLC, LC-MS, ELISA potency, icIEF and peptide map by RP-HPLC.
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Register for this webinar to learn more about the analytical and mitigation strategies for antibody reduction in bioprocessing.